Background Clinical trials in lung cancer increasingly require subjects to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and subject selection have not been fully elucidated. Methods We retrospectively reviewed data generated by patients who consented to one or more interventional lung cancer clinical trials the UCLA Jonsson Comprehensive Cancer Center between January 2013 and December 2014. Trials were considered to require a biopsy when enrollment was conditional on the procurement of tissue without intervening therapy between procurement and enrollment. Results: 311 patients underwent 368 screening incidents for one or more of 19 trials. Trials that required a new biopsy had a longer median screening duration (34 vs. 14 days) than trials that did not require a biopsy (p<0.001). Trials requiring a biopsy had a greater screen failure rate (49.1% v. 26.5%, p<0.001), largely driven by patients who did not undergo the required biopsy or lacked the required biomarker. Worsening performance status led to the majority of screen failures (56.5%) among biomarker-eligible patients. Conclusions: Although the scientific benefits of obtaining a new biopsy and requiring specific results for trial enrollment are clear, it leads to a lengthening of the screening period, which, in some cases, is associated with clinical decline prior to enrollment. Implications for the interpretation of data from studies of this design should be explored.

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ObjectiveSystemic sclerosis (SSc) is associated with several specific risk factors for fracture due to the complications of the disease and related medications. The present study was undertaken to examine the relationship between SSc‐associated clinical features and fracture rate in a large US cohort.MethodsParticipants with SSc in FORWARD, The National Databank for Rheumatic Diseases, were included (1998–2019). Age‐ and sex‐matched individuals with osteoarthritis (OA) from the same database were included as comparators. The primary end point was self‐reported major osteoporotic fracture. Cox proportional hazards models were used to study the associations between risk factors and fractures.ResultsThe study included 922 individuals (SSc patients, n = 154; OA patients, n = 768). Eighty‐seven percent were female, with a mean age of 57.8 years. Fifty‐one patients developed at least 1 fracture during a median of 4.2 years (0.5–22.0 years) of follow‐up. Patients with SSc had more frequent fractures compared to OA comparators (hazard ratio [HR] 2.38 [95% confidence interval (95% CI) 1.47–3.83]). Among patients with SSc, a higher Rheumatic Disease Comorbidity Index score (HR 1.45 [95% CI 1.20–1.75]) and a higher Health Assessment Questionnaire disability index score (HR 3.83 [95% CI 2.12–6.93]) were associated with more fractures. Diabetes mellitus (HR 5.89 [95% CI 2.51–13.82]) and renal disease (HR 2.43 [95% CI 1.10–5.37]) were independently associated with fracture among SSc patients relative to SSc patients without these comorbidities.ConclusionOur findings highlight factors associated with fracture among patients with SSc. Disability as measured by the HAQ DI is a particularly strong indicator of fracture rate in SSc. Improving SSc patients’ functional status, where possible, may lead to better long‐term outcomes.

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